On May 19, 2025, Provision No. 3294/2025 (the “Provision”) issued by the National Administration of Drugs, Food and Medical Technology (“ANMAT” after its spanish acronym) was published in the Official Gazette, establishing the mandatory inclusion of a QR code on the packaging of synthetic or semi-synthetic medicinal products.
The Provision mandates that all synthetic or semi-synthetic medicinal products must include a QR code within one year from the effective date of the Provision. This code must be printed or added as a label with anti-fraud technology on the secondary packaging, and optionally on the primary packaging, where it may coexist with the printed version of the package insert.
The QR code will be issued through a formal request to the Directorate of Clinical Research and Drug Registration Management at the National Institute of Medicines.
This measure came into effect on May 19, 2025.
